Chronic Effects of DBS in Parkinson's Disease and Dystonia (Activa PC+S)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Isolated Dystonia; Parkinson's Disease

Treatments: Device: Activa PC+S

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01934296

Activa PC+S

Details and patient eligibility

About

The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in movement disorders and how they relate to DBS, not to bring new devices to market.

Enrollment: 9 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria(both groups):

• Ability to give informed consent for the study
• Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria

Inclusion criteria (Isolated dystonia):

• Age 22-75
• Isolated dystonia that is generalized or segmental, that must affect one or - Stable doses of anti-dystonia medications (such as Artane, Baclofen, or Clonopin) for at least 30 days prior to baseline assessment
• For patients with craniofacial involvement, prior treatment with botulinum toxin with failure to adequately control dystonia symptoms.

Inclusion criteria (PD):

• Age 30-75
• Bilateral disease (Hoehn and Yahr stage 2 or greater)
• Has been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist
• Stable doses of antiParkinsonian medications for at least 30 days prior to their baseline assessment
• Significant disability in the setting of optimal medical management by a movement disorders neurologist. Disability may be due to tremor that is unresponsive to medications, or to motor fluctuations
• UPDRS-III score off medication between 20 and 60
• Improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score.

Exclusion Criteria (both groups):

• Pregnancy or breast feeding
• MRI showing cortical atrophy out of proportion to age
• MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder,
• Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
• Inability to comply with study follow-up visits
• Any prior intracranial surgery
• Mood depression with a Beck depression inventory score of > 17 on baseline screening
• Significant cognitive impairment (MoCA<25).
• History of seizures
• Immunocompromised
• Has an active infection
• Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic - Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

chronic brain recording

Experimental group

Description:

This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.

Treatment:

Device: Activa PC+S